Cytodyn Inc (CYDY)

[BlackDoggie]

I'm sure that you're correct here about typical label expansion procedures. The one bit of speculation I may have here is that the FDA may consider expanding the label to instances of fewer classes of drug resistance based on two things:

1) The safety profile appears stellar, so that's not much of a concern barring new developments.

2) While the combo market described by the trial participant criteria is very small, it's possible that addressing instances of drug resistance earlier (i.e. before multiple classes fail and patients live with an elevated viral load for prolonged periods of time) would keep more patients from progressing to multi-tropism. Ibalizumbab would still be there if they were to progress, but I would think that overall treatment goal should be inhibiting disease progression as early and effectively as possible. Testing could be ongoing as a post-approval P4.

Maybe that's wishful thinking on my part, and it doesn't change that the real money is in mono, but it seems to me that the FDA would have the incentive to expand the labeling without requiring additional trials pre-approval. The safety data appears to support that at the moment, as well. Then again, and not to rub salt in the wound since it's my wound as well, but that's along the lines of what we thought about Rexista! Just never know with the FDA.